FDA Appears Poised to Restrict the Sale of Flavored E-Cigarettes

A March 1 article on Axios indicates that the FDA is poised to formally implement a policy that would severely restrict the sale of flavored e-cigarettes in retail environments. In a November 15, 2018 statement, FDA Commissioner Scott Gottlieb had announced a plan to prohibit flavored ENDS products (other than tobacco, mint and menthol or non-flavored products) that are not sold in an age-restricted, in-person location. At the time, Commissioner Gottlieb indicated that the FDA would provide additional details “soon,” and suggested that in the interim manufacturers voluntarily remove flavored ENDS from convenience stores. Some manufacturers did just that.

The FDA now appears ready to implement this policy. The Axios article indicates that on March 1, Commissioner Gottlieb presented White House staff with his plan, which is apparently the final step before implementation. Apparently the plan will not involve an outright ban on flavored ENDS in convenience stores, but rather would mandate that flavored ENDS can only be sold in age-restricted environments. In other words, any retail store that wants to sell flavored ENDS can do so only if it checks the identification of everyone entering the location. For example, a convenience store wanting to sell flavored ENDS would have two choices: (1) check the identification of everyone entering the store, or (2) build a separate room to sell flavored ENDS, and require identification before entering that room. Given the likely infeasibility of either approach in most convenience stores and gas stations, this could be tantamount to a ban on flavored ENDS in most retail environments.

If implemented, the proposal could be challenged in court under the Administrative Procedure Act. A new requirement for sales in face-to-face transactions could be regarded as the equivalent of an agency regulation, which normally must go through the notice-and-comment process under the APA. Such a requirement also could violate Section 906 of the Family Smoking Prevention and Tobacco Control Act, which bars the FDA from “prohibit[ing] the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets.”

The proposal presented to the White House last week apparently does not involve other elements of Commissioner Gottlieb’s November 2018 statement, including “heightened age verification processes” for online sales of flavored ENDS, a potential ban on flavored cigars and a potential ban on menthol in combusted products.

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